Benign Prostatic HypertrophyPhase 4NCT01260129
Safety and Efficacy of QD Versus BID Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH
A Phase 4 study testing Silodosin in people with Benign Prostatic Hypertrophy, run by JW Pharmaceutical at 14 sites in South Korea.
Trial summary
Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy
- What is being tested?
- Silodosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Oct 2010to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed with BPH through digital rectal exam or ultrasonographic findings and meet the following criteria.
- Outpatients aged 50 or over
- Patients with a total I-PSS score of 8 or higher and a QoL score of 3 or higher
- Patients with a prostate volume measured by transabdominal ultrasonography, or TRUS of 20 ml or greater
- Patients with a maximum urinary flow rate (Qmax_) of 15ml/sec or below (whose a void urinary volume of 120ml or greater)
Who cannot join
- Patients with a residual urinary volume of 200ml or greater
- Patients with a history of prostatectomy
- Patients with a history of intrapelvic radiation therapy
- Patients with a history of prostatic hyperthermia
- Patients with prostate cancer or suspected prostate cancer
- Patients with complications considered likely to affect urinary passing such as neurogenic bladder, bladder calculus and active urinary tract infection. UTI
Show all 18Show fewer
- Patients conducting self-catheterization
- Patients with renal impairment (serum creatinine of 3.0 mg/dl or greater)
- Patients with severe heptic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or with a total bilirubin of 3.0mg/dL or greater or AST/ALT 2.5 times higher than normal level
- Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
- Patients with a history of an allergy to α-blockers
- Patients with orthostatic hypotension at around screening visit
- Patients with an experience of other investigational product treatments within 4 weeks form screening visit.
- Patients with a PSA of 10 or over, Patients with tumor identified by a prostate biopsy with a PSA of 4 or over (For patients taking 5α-reductase inhibitors for more than 3 months are presumed to have double than their actual PSA levels.)
- Patients who have taken unstable doses of antidepressants within the 3 months or who are expected to take unstable doses during the study
- Patients who have taken alpha blockers within the 2 weeks from the start of the therapy
- Patients who have taken unstable doses of 5α-reductase inhibitors within the 3 months from the start of the therapy or who are expected to take unstable doses during the study.
- Patients disqualified by the investigator.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
The Catholic Univ., Bucheon ST.Mary's Hospital
Bucheon-si
Busan National Univ. Hospital
Busan
Konkuk Univ, Chungju Hospital
Chungju
Choongnam National Univ. Hospital
Daejeon
Eulji Univ. Hospital
Daejeon
Chonnam Univ. Hospital
Hwasun
Inha Univ. Hosipital
Incheon
Asan Medical Center
Seoul
Chungang Univ. Hospital
Seoul
Korea Univ. Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
The Catholic Univ., Seoul ST.Mary's Hospital
Seoul
About this study
Official title: Safety and Efficacy of 8mg Once-daily Versus 4mg Twice-daily Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH ; 12-week, Double-blind, Randomized, Comparison, Multi-center Study
Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety.
Read the detailed description
Silodosin is a highly selective α1A-adrenoceptor antagonist for the treatment of the signs and symptoms of BPH. 4mg Silodosin twice daily has been approved in Asia including Japan and Korea. In US, 8mg Silodosin once daily with the FDA approval is already available. Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety. The study used double-blind, random assignment in Korean men with signs and symptoms of BPH for 12 weeks.
- Conditions
- Benign Prostatic Hypertrophy
- Being tested
- Silodosin
- Keywords
- BPH, silodosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Silodosin 8 mg orally, once daily after morning meal
SilodosinDrug
Silodosin 4 mg orally, twice daily after morning and evening meal
| Study group | Role | What they receive |
|---|---|---|
| Silodosin 8 mg | Experimental | Not described Receives: Drug: Silodosin |
| Silodosin 4 mg | Experimental | Not described Receives: Drug: Silodosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
I-PSS
Change in I-PSS total score from baseline
Measured: 12 weeks
Secondary outcomes (1)
I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question
- The rate of patients who experience a decrease in I-PSS total score of 25% or higher
- The rate of patients who experience an improvement of at least 4 in I-PSS total score I-PSS
- Change in Qmax from baseline
- The rate of patients who experience an improvement of 30% or over in Qmax
- Change in the I-PSS voiding and storage scores from baseline
- Change in QoL score from baseline
- Change in ICS Male Questionnaire from baseline
- Patient's goal achievement score
- Treatment Satisfaction Question
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae Seung Paick, ph.D, Principal investigator, Department of Urology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260129
- Sponsor's protocol ID
- CWP-SDS-401
- Status last verified
- Mar 2012
- First submitted
- 28 Oct 2010
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of 8mg Once-daily Versus 4mg Twice-daily Silodosin With Lower Urinary Tract Symptoms Suggestive of BPH ; 12-week, Double-blind, Randomized, Comparison, Multi-center Study
- ClinicalTrials.gov ID
- NCT01260129
- Acronym / sponsor ID
- CWP-SDS-401
- Conditions
- Benign Prostatic Hypertrophy
- Keywords
- BPH, silodosin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety.
Detailed description
Silodosin is a highly selective α1A-adrenoceptor antagonist for the treatment of the signs and symptoms of BPH. 4mg Silodosin twice daily has been approved in Asia including Japan and Korea. In US, 8mg Silodosin once daily with the FDA approval is already available. Korea has newly adopted 8mg Silodosin once daily. Against these backdrops, this clinical study is designed to demonstrate that the newly adopted dose is not inferior to the existing dose in its efficacy and safety. The study used double-blind, random assignment in Korean men with signs and symptoms of BPH for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silodosin 8 mg | Experimental | Drug: Silodosin |
| Silodosin 4 mg | Experimental | Drug: Silodosin |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have been diagnosed with BPH through digital rectal exam or ultrasonographic findings and meet the following criteria.
- Outpatients aged 50 or over
- Patients with a total I-PSS score of 8 or higher and a QoL score of 3 or higher
- Patients with a prostate volume measured by transabdominal ultrasonography, or TRUS of 20 ml or greater
- Patients with a maximum urinary flow rate (Qmax_) of 15ml/sec or below (whose a void urinary volume of 120ml or greater)
Key exclusion criteria (18 listed)
- Patients with a residual urinary volume of 200ml or greater
- Patients with a history of prostatectomy
- Patients with a history of intrapelvic radiation therapy
- Patients with a history of prostatic hyperthermia
- Patients with prostate cancer or suspected prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilodosinSilodosin 8 mg orally, once daily after morning meal | Drug | Silodosin 8 mg |
| SilodosinSilodosin 4 mg orally, twice daily after morning and evening meal | Drug | Silodosin 4 mg |
Primary outcome
I-PSS
Time frame: 12 weeks
Change in I-PSS total score from baseline
1 secondary outcome
I-PSS, Qmax, QoL, ICS Male Questionnaire, goal achievement, Treatment satisfaction question
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Seung Paick, ph.D principal investigator
Department of Urology, Seoul National University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silodosin in people with Benign Prostatic Hypertrophy, run by JW Pharmaceutical at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-PSS (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2012.